Mini-PNCL vs fURS in Management of Nephrolithiasis

NCT04389853 | Completed

• 1 other identifier: RP-645
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm. Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates. To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.

Conditions

Nephrolithiasis; Kidney Stone

Outcome Measures

Primary Outcomes (2)

• Stone-free status

  Operation success will be evaluated with a non-contrast computed tomography (CT) scan on the first post-operative day, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan

  1-day

• Stone-free status

  Operation success will be re-evaluated with a non-contrast computed tomography (CT) scan at 4-weeks post-operation, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan

  4-weeks post-op

Secondary Outcomes (5)

• To compare safety measures

  4 weeks

• To compare stone free status of single use vs reusable fURS

  1-day post-op

• To compare stone free status of single use vs reusable fURS

  4-weeks post-op

• Assess the postoperative pain between both techniques

  1-day post-op

• Assess the postoperative pain between both techniques

  4-weeks post-op

Study Arms (2)

Flexible ureteroscopy (fURS)

ACTIVE COMPARATOR

Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.

Procedure: Flexible ureteroscopy

Mini-percutaneous nephrolithotomy (mini-PCNL)

ACTIVE COMPARATOR

PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4

Procedure: Mini-percutaneous nephrolithotomy

Interventions

Flexible ureteroscopy PROCEDURE

Retograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.

Flexible ureteroscopy (fURS)

Mini-percutaneous nephrolithotomy PROCEDURE

PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).

Mini-percutaneous nephrolithotomy (mini-PCNL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects over 18 years of age at the time of enrollment.
• Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Congenital anatomic anomalies of the kidney, ureters or bladder.
• Previous ipsilateral renal surgery within past five years.
• Patients with ipsilateral distal ureteral stones or stricture.
• Stone size \> 20 mL or multiple kidney stones in different calyces.
• Previous SWL treatment for the same stone.
• Patients presented with a previously inserted ipsilateral ureteral stent.
• Participants with active urinary tract infection until appropriately treated
• Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
• Pregnancy or morbid obesity
• Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
• Participants who are uncooperative or cannot follow instructions.
• Participants who lack the capacity to provide free and informed written consent.
• Patients with solitary kidney.

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute

Thunder Bay, Ontario, P7B6V4, Canada

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hazem Elmansy, MD

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Surgeon

Model Details: Randomized Control Study comparing two standard of care treatments.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 15, 2020
• Study Start: October 5, 2020
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)